Services

Regulatory Affairs

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Regulatory Affairs guidance, creation and filing of all types of submissions for drugs and medical devices in Canada  including:

  • Regulatory Filing Strategy 
  • Due Diligence and Regulatory Gap Analysis
  • Pre-submission meetings with Health Canada (TPD and BGTD) 
  • Preparation of Submissions: New Drug Submissions (NDS & ANDS), Supplemental New Drug Submissions (SNDS &ASNDS), Notifiable Changes (NC), Annual Notifications, Annual DIN Renewals, Drug Identification Number (DINs) 
  • Label Negotiations with Health Canada
  • Clinical Trial Applications for drugs and Medical Devices 
  • CPP and CEP 
  • Label Creation and Review ( pre and post approval)
  • Medical Cannabis Licence Applications, Amendments and Notifications

Promotional Materials Review

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  • Review of advertising (Patient/Healthcare) and promotional materials (digital, print, sales detail aids) to ensure compliance to Canadian advertising regulations and PAAB guidelines

Quality Operations

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  • Creation and review of GMP SOP’s 
  • Drug Establishment Licence (DEL) and Medical Device Establishment Licence (MDEL) applications and submissions 
  • Assistance with and Hosting of Health Canada GMP Audits 
  • GMP Compliance Gap Analysis 
  • Production Records Review and Product Release for Canadian Market
  • Distribution channels' alignment with Canadian GMP guidelines
  • Creation of Quality Agreements with suppliers and third party logistics vendors
  • Inspection readiness training (On-Site Evaluation by BGTD and routine GMP inspections)